Basaglar FDA Approval History
FDA Approved: Yes (First approved December 16, 2015)
Brand name: Basaglar
Generic name: insulin glargine
Dosage form: Injection
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes, Type 1, Diabetes, Type 2
Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in patients with type 1 and type 2 diabetes mellitus.
Basaglar is similar to Lantus (insulin glargine injection) though it is not approved as a biosimilar product. Basaglar was approved through an abbreviated approval pathway that included data from two Basaglar-specific clinical trials, and additional evidence that demonstrated Basaglar was sufficiently similar to Lantus to justify its safety and effectiveness.
Basaglar is administered by subcutaneous injection once daily at the same time each day.
The most common side effects reported during clinical trials included hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema, and weight gain.
Development Timeline for Basaglar
|Dec 17, 2015||ApprovalFDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes|
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